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Drug Manufacturer Receives Fast Track Designation From FDA
Posted @ 11-Jul-09 22:14 under MS by pmbTags: biogen, double blind placebo, drug manufacturer, fast track, interferon beta 1a, MS, new drugs, News, phase iii, promising results, relapsing remitting ms
Pharmaceutical firm Biogen Idec announced that the American drug watchdog the Food and Drug Administration (FDA) has granted Fast Track designation for its multiple sclerosis (MS) drug PEGylated interferon beta-1a (BIIB017).
The company is currently enrolling patients in a global Phase III study evaluating the effectiveness and safety of either bi-weekly or once-monthly injections of the therapy in people with relapsing remitting MS.
If the trial reports promising results it means that people could inject their medication less often without sacrificing effectiveness.
The FDA’s Fast Track program is designed to speed up the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
Biogen Idec plans to enrol more than 1,200 patients with relapsing remitting MS in the Phase III, randomized, double-blind, placebo-controlled trial called ADVANCE designed to evaluate the effectiveness and safety of PEGylated interferon beta-1a.
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